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FDA 510(k)

Racz Neurostat RF Generator

K-Number: K232632 · 2024-05-24

ApplicantEpimed International
Decision Date2024-05-24
Product CodeGXD
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Racz Neurostat RF Generator is the device name listed in this FDA 510(k) record. The listed applicant is Epimed International. It received FDA 510(k) clearance on 2024-05-24 under 510(k) number K232632. The device is classified under product code GXD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Racz Neurostat RF Generator?

Racz Neurostat RF Generator is a medical device that received FDA 510(k) clearance on 2024-05-24. The listed applicant is Epimed International. The 510(k) number is K232632.

When did Racz Neurostat RF Generator receive FDA 510(k) clearance?

Racz Neurostat RF Generator received FDA 510(k) clearance on 2024-05-24, under 510(k) number K232632.

Who is the listed applicant for Racz Neurostat RF Generator?

The FDA 510(k) record lists Epimed International as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Racz Neurostat RF Generator?

The FDA product code for Racz Neurostat RF Generator is GXD.

Other records listing Epimed International as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200624Percutaneous IntroducerK190256Rulo Radiofrequency Lesion Probe

Related Devices (Code: GXD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251247GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)Boston Scientific Neuromodulation CorporationK242057COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)Avanos Medical, Inc.K231675OneRF Ablation SystemNeuroone Medical Technologies Corp.K220122APEX 6Rf Innovations, Inc.K203293Abbott Medical Grounding Pad, model RF-DGP-ISABBOTT MEDICALK201610IonicRF GeneratorABBOTT MEDICAL

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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